Medical boot for patient with diabetic foot

ABSTRACT

A medical diabetes treatment boot can be equipped with a cushion placed inside the boot against an upper rear portion of the boot, to promote flotation support for the wearer&#39;s ankle when the cushion includes a soft midsection panel adapted to engage the ankle rear surface; a deformable fluid-containing pouch is removably disposed in a hollow interior space within the panel to provide ankle support. The pouch can be removed through a rear access opening that is normally closed by a zipper closure.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of application Ser. No. 08/707,725, filedSep. 4, 1996, now U.S. Pat. No. 5,797,862.

This application is a continuation-in-part of U.S. patent applicationSer. No. 08/521,962, filed Aug. 31, 1995, and since issued as U.S. Pat.No. 5,762,622, Jun. 19, 1998, for "Medical Boot With Unitary Splint";U.S. application Ser. No. 08/343,090, filed Nov. 21, 1994 and sinceissued as U.S. Pat. No. 5,609,570, Mar. 11, 1997, for "ProtectiveMedical Boot and Orthotic Splint"; and also related to ProvisionalApplication Ser. No. 60/003,241 filed Sep. 5, 1995 for "Medical Boot forPatient With Diabetic Foot."

BACKGROUND OF THE INVENTION

About twelve percent of the population, that is millions of people,suffer from diabetes. Of this number, many suffer from lower leg andspecifically foot complications, such as diabetes mellitus, chronicthrombophlebitis, malnutrition and vitamin deficiency, carcinoma,multiple sclerosis, uremia, vascular disease, and venus stasis ulcers.These conditions, if not treated, and supported properly, can result inthe loss of the patient's limb.

SUMMARY OF THE INVENTION

The broad purpose of the present invention is to provide an insole forthe medical boot disclosed in my co-pending patent applications as wellas my prior U.S. Pat. No. 5,226,245 which issued Jul. 13, 1993. Myearlier boots are sold under the trademark T-Boot and Demi-Boot whichare respectively a large boot and a smaller boot depending upon the sizeof the patient.

My novel insole will be provided in three sizes, small, medium and largeand two types of laminations. A universal width gives generous room forthe diabetic foot. The insole body is a multiple density compositecomprising a blue elastic polymer which is unlike foam rubber, whichbreaks down. The elastic polymer functions are: 1. proper weightdistribution; 2. shock and shear absorption and dissipation; 3. postingto accommodate or correct bio-mechanical deficiencies. The polymer, whenused as an insole, flows perpendicular to the force of the patient'sweight, slowing the velocity prior to impact, then rebounds slowly toreduce after-shock. The material responds to shear force by twistinginternally like a liquid ball bearing, so that no shearing action isapparent to the surface.

A pink Plastazolt material is bonded to the blue elastic polymer.Plastazolt is known as a leading material for orthotic appliancefabricators for making custom molded inlays for a number of years. Itcan be combined with different types of substrate such as foam rubber,which has a tendency to deteriorate in a very short period of time. ThePlastazolt permits an impression of the patient's foot. The Plastazoltcan be molded to form an impression of the configuration of the bottomof the patient's foot, by heating the surface to a 130° F. forapproximately three to four minutes, that is in a relatively shortperiod of time. A patient's own body weight and temperature will alsomold the material in the same way during a period of one to two days.

The polymer and the Plastazote are laminated together and combined ontop of a thin plastic insole. The two insoles are then disposed in acover of blue tricot or similar material which has a toe pocket and aheel pocket to hold the two insoles firmly in place. The insole coverhas a pair of integral straps that wrap around the bottom of the insolesto assist in connecting the cover to the insole. The assembly is thenplaced into the bottom of the medical boot disclosed in my priorapplications and patent and held in position at the heel portion by hookand loop fabric fasteners. The toe is anchored to the boot by a pair ofsnap fasteners, or hook and loop fabric fasteners.

The soft laminated insole may also be a combination of a Poron materiallaminated to the Plastazote material. The Poron material is a frothed,open cell urethane sheet that is breathable, comfortable, odorless,washable and non-sensitizing. It absorbs shock, cushions and will recoilwithout bottoming out.

For greater customization, a metatarsal pad made of the same elasticpolymer is attached by an adhesive that is located according toreference markings on the blue polymer insole. The pad lifts a portionof the patient's sole and reduces pressure to the metatarsal heads, thusreducing skin breakdown and ulcer formation. Ulcer formation in thediabetic patient can lead to infection and possible amputation if nottreated and supported in very early stages. Scaphoid pads are of thesame elastic polymer material but are generally wedge-shaped andattached by an adhesive applied to the bottom of the polymer insole.These pads provide greater cradle support to the arch of the patient'sfoot, and provide a significant anatomical fit which also reducespressure and tissue breakdown. The metatarsal pads and scaphoid pads canbe used as wedges for the hind foot, fore foot, or both, in the middleor the side. The wedges transfer weight while standing or duringambulation, to the opposite side of the foot for added support,stabilization, equalized weight distribution or balance.

A combination of the diabetic insole together with the soft upper bootof my medical boot protects both the lower leg and foot. It providesdrastic cost savings over custom made leather shoes and custom moldedinserts.

The polymer insoles can be trimmed and placed into a regular street shoeor athletic shoe when the insole of the street shoe or athletic shoe isremoved creating a 1/4" recess.

The polymer insole, when utilized with my soft medical boot, offers evengreater advantages for splinting the foot, ankle or leg to offer moresupport. The splint integrates into the boot while accommodating theinsole. Thus, my product provides three appliances in one:

1. wound care protection (body of boot material);

2. bracing for the lower leg and foot with an integrated splint;

3. custom fitted, hi-tech polymer insole for support and pressurereduction to the plantar surface of the foot.

When these three items are combined, my product becomes a multi-poroussplint brace with a customized polymer insole. Other multi-poroussplints are available, but do not offer a multiple inlay for ambulation.

A further object is to provide an improved hydro-cushion pillow overthat disclosed in my U.S. Pat. No. 5,226,245.

The improved cushion now extends to the calf area to protect the legfrom pressure or abrasion from the splint. The gel in the cushionprotects the patient's heel in bed, walking or sitting in a wheelchair,cushioning and absorbing pressure. The cushion has a zipper to permitthe gel to be removed during ambulation, to reduce the weight of theboot, but still giving padding to the lower calf and wings of thecushion. This in turn gives greater stability to the internal andexternal ankle portion of the foot. The zipper also permits the gel tobe removed for washing and drying of the cushion cover.

In order to further fasten the boot to the patient's foot, the boot solehas slots which accommodate a strap that is fed through the slots andthen wrapped around the boot and the foot. The strap ends are connectedby hook fabric fasteners to the boot material to compress the bootagainst the foot, holding the foot stable and eliminating constrictiondirectly against the foot.

An upper strap wraps around the patient's ankle and the ankle portion ofthe boot.

The upright portion of the splint has slots for recovering themid-section of the upper strap. This strap is identical to the footstrap, with hook fabric fasteners that can be connected either to theboot material or the strap end.

The splint is connected to the boot by a snap fastener at the top of thesplint, and a pair of snap fasteners that connect the inside toe coverto the toe of the boot. A cap at the top of the splint prevents abrasionof the calf area.

Still further objects and advantages of the invention will becomereadily apparent to those skilled in the art to which the inventionpertains upon reference to the following detailed description.

DESCRIPTION OF THE DRAWINGS

The description refers to the accompanying drawings in which likereference characters refer to like parts throughout the several views,and in which:

FIG. 1 is a perspective view of a soft medical boot with a diabeticinsole illustrating the preferred embodiment of the invention;

FIG. 2 is a view of the boot and insole of FIG. 1 when viewed throughthe open toe;

FIG. 3 is a view of the bottom of the polymer insole;

FIG. 4 is a view of the Plastazote insole with an image of the patient'sfoot illustrated in phantom;

FIG. 5 is an enlarged cross-section as seen along lines 5--5 of FIG. 3;

FIG. 6 is a view of a patient forming an impression of his foot in thePlastazote side of the insole;

FIG. 7 shows the manner in which the metatarsal pad elevates themid-section of the patient's foot to relieve the pressure to themetatarsal heads;

FIG. 8 is a view generally at right angles to the view of FIG. 7 to showthe location of the metatarsal pad and wedges;

FIG. 9 is a view of the relatively rigid plastic insole;

FIG. 10 illustrates the heel and toe covers for the preferred insole.

FIG. 11 is a view of another embodiment of the invention which includestwo additional straps;

FIG. 12 is a bottom view of the foot portion of the embodiment of FIG.11;

FIG. 13 is a rear view of the calf portion of the embodiment of FIG. 11;

FIG. 14 is a view of a cushion that may be folded and used in theinternal heel portion of the embodiment of FIG. 11;

FIG. 15 is a view of the opposite side of the view of FIG. 14 to showthe zipper closure.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the drawings, FIGS. 1 and 2 illustrates a soft medical boot10 showing a preferred diabetic insole assembly 12. Boot 10 has a heightof about 10" and a length from heel to toe about 10". The boot has anupper leg portion 14 and a sole 16. The boot is formed of a singlemulti-layer sheet containing the profile of the leg portion in the sole.The sole is formed from a pair of edges that are stitched together toform a seam 18 extending from the heel to the toe of the boot.

The boot material is made of an elastomeric shape-retaining material,such as a soft, flexible, compressible, open cell polyurethane foam corewith an outer layer of an ultra-smooth, soft, non-allergenic cloth suchas brushed tricot. This fabric is characterized by a continuous layer ofsmall loops which make the material compatible with fabric hookfasteners means such as fasteners marketed under the trademark VELCRO.The entire outer cover, including both the upper portion of the boot andthe sole has a brushed tricot covering so that a patch of a Velcro hookmaterial can be connected at any location on the boot exterior.

The entire edge of the boot above the sole is heat fused and compressedtogether as at 19 and cut to the boot configuration all in one process.

The boot has a pair of cooperating foot straps 20 and 22, and a pair ofcooperating leg straps 24 and 26. Foot strap 22 has a patch 28 of afabric hook material which may be connected to a complementary patch 30of a fabric loop material on strap 20 to close the boot around apatient's foot to form a relatively large toe opening 32. Similarly theleg straps have cooperating patches of fabric hook arid loop fastenermaterial to close the boot to the position illustrated in FIGS. 1 and 2,such that the boot encircles the user's lower calf.

The top rear of the boot has a recessed area at 34 which extends downabout 11/2" from the top of the boot, and is about 31/2" wide to protectthe rear of the user's leg against skin irritation and to preventconstriction of capillary flow in the lower calf area of the leg.

Referring to FIG. 1, the boot heel has an opening 36 that is about 23/4"wide from side to side and is about 1/4" tall for receiving a splint,not shown, but disclosed in my co-pending patent application, and toprovide greater air circulation in the heel area.

Referring to FIGS. 3, 9 and 10, diabetic insole assembly 12 comprises ahard insole 40, a plastic insole 42, and a cover 44 which holds the twoinsoles together as a unit.

FIG. 10 shows the cover and the insoles 40, 42 in the upside downposition. Hard insole 40 is elongated with a toe end 46 and a heel end48. The hard insole is available in various lengths, such as small,medium and large for a typical boot. The hard insole and cover 44 extendbeyond the toe opening of the boot so that the patient's toes are wellventilated. Hard insole 40 is formed of a relatively rigid polypropyleneplastic material and is about 1/4" thick, and for illustrative purposesmay be 91/2" long. The hard insole provides some foundation support forthe patient when he is either walking with the boot or confined to bed.

Insole cover 44 has a top layer 50, as seen in FIG. 1, formed with asoft foam interior and a brushed tricot upper surface to provide a softsurface contacting the sole of the patient's foot. Referring to FIG. 10,the bottom side of the cover has a pair of pockets 52 and 54 forreceiving the toe and heel respectively of the two insoles.

Pocket 52 has a pair of male snap fasteners 56 and 58 which mate with apair of female snap fasteners (not shown) fastened to the bottom of theboot. The snap fasteners locate the insoles and prevent them fromslipping in the boot as the patient is either walking or lying in asupine position. A patch of a Velcro hook-shaped fabric fastener means64 is attached to the bottom of heel pocket 54 for connecting the linereither to the heel portion of the boot or to the foot portion of asplint (not shown).

Referring to FIGS. 3 to 8, insole 42 is a multiple density compositecomprising a blue lower polymer layer 66 and a pink Plastazote top layer68 bonded to layer 66. Plastazote is a material used for forming theimpression of a patient's foot 70 as illustrated in FIG. 6. The surface72 of the Plastazote is heated to approximately 130° for three to fourminutes, as by a hair dryer or the like. The patient's foot is thenplaced on the Plastazote to form a recessed impression 74. When heremoves his foot, impression 74 forms a permanent recessed area in thePlastazote. The impression is illustrated generally in FIGS. 6 and 7,and at 76 in phantom in FIG. 4.

Referring to FIGS. 3, 7 and 8, a metatarsal pad 80 made of the sameelastic polymer as layer 66 is attached to the bottom of layer 66 andlocated according to reference marking 81. Pad 80 when placed on hardinsole 40 lifts the bottom of the patient's foot as illustrated in FIG.7, thereby reducing pressure to the metatarsal heads and reducing thepossibility of skin breakdown and ulcer formation.

Referring to FIG. 8, a pair of wedge-shaped scaphoid pads 82 and 84 canalso be attached by a suitable adhesive, to the flanged or winged areas86 and 88 of polymer layer 66. Flanged areas 86 and 88 swing away fromthe plane of the layer by virtue of small groove means 90 as illustratedin FIG. 5 which permit the two flanged areas to swing up to thepositions illustrated in FIG. 8. This permits the soft insole to providelateral support to the patient's foot when it is disposed inside thesoft boot, illustrated in FIG. 2.

FIGS. 11, 12 and 13 illustrate another embodiment of the invention inwhich boot 10 has an additional strap 100 encircling the foot portion ofthe boot, and another strap 102 encircling the calf portion of the boot.Strap 100 and 102 are each about 21" long and 21/4" wide. The strap isformed with an outer layer that is the same as the outer layer of theboot, that is an ultra-smooth, soft, non-allergenic cloth such asbrushed tricot. The outer layer has a continuous layer of small loopsthat makes the material compatible with fabric hook fasteners. The innerlayer, that is the layer facing the boot, is preferably formed of a softwicking material. Strap 100 preferably has a patch of a fabric fastenerhook material as illustrated at 104 adjacent one end of the strap and asecond patch of a fabric fastener hook material 106 adjacent theopposite end of the strap. Thus the strap can be wrapped around the footportion of the boot and the ends attached either to the outer layer ofthe opposite end of the strap, or to the boot material itself.

Referring to FIG. 12, the sole of the boot has a pair of slots 108 and110 for receiving the midsection of strap 100. The outer ends of thestrap are attached to the boot as illustrated in FIG. 11.

Similarly, strap 102 is identical to strap 100 and has a pair of fabrichook fastener patches 112 and 114 attached to the inner layer of thestrap adjacent its ends so that they can be fastened to one another asillustrated in FIGS. 11.

Referring to FIG. 13, when the boot is used with a splint 116 having anupright section that extends up the rear calf of the user, the splinthas a pair of slots 118 and 120 for receiving the midsection of strap102 and locating it in position. The strap can be used directly on theboot when the splint is not being used.

A cloth cap 122 mounted on the upper end of the splint has a patch 124of a fabric hook fastener attached to the boot cover. In addition, snapfastener means 126 carried on the splint and the boot also attach thesplint to the boot.

FIGS. 14 and 15 illustrate a cushion 130 which may be folded and usedinside the boot adjacent the rear opening in the manner described in myprior U.S. Pat. No. 5,226,245 which issued Jul. 13, 1993 for "ProtectiveBoot Structure". The cushion may be used behind the heel cord of thepatient. The cushion is formed in a unitary structure. The cushion has acentral somewhat rectangular midsection panel 132 connected to a topsmaller rectangular panel 134 along a stitched fold line 136. Thecushion also has a pair of side panels 138 and 140 connected to themidsection panel along stitched fold lines 142 and 144 respectfully.

The midsection panel, the top panel and the side panels all house anelastomeric shape-retaining material such as a soft flexiblecompressible open core polyurethane foam or the like. The side of thecushion facing the patient's foot, including all four panels, is formedwith a covering at 146 of a soft material having good wickingcharacteristics as is the opposite side of the two side panels. The sideillustrated in FIG. 15, which faces the inner surface of the boot,including top panel 134 and midsection panel 132 are formed with thesame material as the outer covering of the boot body, that is anon-allergenic brushed tricot having a continuous layer of small loopscompatible with Velcro hook fasteners.

Midsection 132, illustrated in FIG. 15 has a central access opening at150 running along the panel centerline for the full height of panel 132,fastened to a zipper closure 152 secured to the edges of opening 150 forproviding access to the hollow interior of the panel. A zipper handle154 is employed by the user for zipping or unzipping the closure. InFIG. 15 the zipper is illustrated as being in the fully closed position.

The hollow interior of the midsection panel houses a fluid-containingpouch generally indicated in phantom at 156 which entirely fills theinterior of the panel. The zipper permits pouch 156 to be removed sothat the cushion cover can be cleaned. Pouch 156 is an easily deformablefluid containing pouch of the type described and shown in FIGS. 4, 6 and7 U.S. Pat. No. 5,226,245, incorporated herein by reference; the pouchprovides flotational support for the wearer's ankle when the wearer isin a supine position. Strips of fabric hook-shaped fasteners and matablewith the boot cover 158 and 160 are attached to the rear surface of themidsection panel, parallel to the zipper closure, whereby cushion 130can be detachably fastened to the upper rear section of the medicalboot; the preferred cushion location is within the boot behind thewearer's ankle, such that the midsection panel faces the rear surface ofthe wearer's ankle, and the side panels are disposed between interiorside surfaces of the boot and side surfaces of the wearer's ankle.Preferably the strips are each about 1" in width and about 4" in lengthin order to connect the pouch in a selected location to the interior ofthe boot.

Having described my invention, I claim:
 1. In a medical boot formedprimarily of soft, flexible, compressible, shape-retaining material,said boot including an upper rear section having an interior face andadapted to extend behind the wearer's ankle, and upper side sectionsadapted to cover side surfaces of the wearer's ankle, the improvementcomprising:a cushion means adapted for disposition within said boot forcushioning and supporting the wearer's ankle, said cushion means beingformed of a soft flexible compressible shape-retaining core material anda soft cloth covering; said cushion means comprising a midsection paneladapted to fit against the upper rear section of the medical boot, a toppanel extending above the midsection panel, said top panel adapted toextend to the calf area to protect the leg from pressure and abrasion;and two side panels extending from said midsection panel along stitchedfold lines for disposition along the upper side sections of the medicalboot; said midsection panel having a hollow-interior space, a rearsurface adapted to fit against the boot upper rear section interiorface, and a front surface adapted to fit against the wearer's ankle;said midsection panel and connected thereto by a stitched fold linehaving an imaginary centerline located midway between the side panels,and an access opening for the hollow interior space extending along saidcenterline, said access opening being located on the rear surface of themidsection panel so that the front surface of the midsection panel iscontinuous and uninterrupted; a deformable fluid-containing pouchremovably disposed within the hollow interior space of the midsectionpanel for flotational support of the wearer's ankle when the wearer isin a supine position; a zipper means for releasably closing the accessopening in the rear surface of the midsection panel; and fastenerpatches on the rear surface of said midsection panel in spaced relationalongside said zipper means for attaching the cushion means to themedical boot.